In endoscopic procedures, endoscopes are inserted through an orifice or incision and through the body lumen. The endoscope may be guided through internal body lumens, e.g., the gastrointestinal tract, to a region of interest, such as the stomach, cecum, duodenum, small intestine, large intestine, or esophagus. The instruments are provided with a fiber-optic, charge-couple device (CCD), or a CMOS camera, which enable images to be transmitted along the flexible endoscopes and reproduced on a display external to the body of the patient. Accordingly, it is possible to view the internal surfaces of body lumens during these procedures. For example, a gastroscope may be used to view the internal surfaces of the esophagus, stomach, or duodenum.
Endoscopic procedures may be used to provide visual diagnosis (e.g., of an ulceration or polyp), treatment, biopsy, and/or removal of tissue. While colonoscopic and enteroscopic examinations may be effective techniques to assess the state of health of an internal body region, they may cause complications and, in some instances, may fail to allow a clinician to accurately visualize a region of interest. For example, a clinician may not be able to complete the procedure, may fail to detect a polyp, lesion, or other structure, or may cause injury to the body lumen in which the endoscope is inserted, e.g., via the application of traumatic force, which may result in inflammation, burns, bleeding, scarring, perforation, or other injury.
Endoscopic procedures may be time consuming for patients and medical personnel alike, depending upon how difficult it is to advance a scope through the body lumen or to view the surrounding region. Increased procedure times require a patient to be sedated for longer periods, may increase patient discomfort, and thus may increase recovery time. Additionally, there is an in-hospital recovery period, which may last several hours while the anesthesia wears off, and, during that time, clinical observation is needed. Increased procedure time further cuts down on the number of procedures that a given team of clinicians can perform in one day and limits the use of an operating room.
Anatomical and technological limitations may also contribute to the difficulties of these procedures. First, the anatomy of a body lumen, e.g., the colon, may be tortious, and the lining may be uneven. For example, the colon is arranged into a series of folds. As the tip of the endoscope passes along the lumen of the colon, these folds may hamper the clinician's ability to visualize the entire surface of the mucosa and, in particular, to detect pre-malignant and malignant lesions and polyps located along these folds. For example, during endoscope withdrawal, lesions located on the distal faces of these folds may not be visualized.
Second, the tip position of the endoscope may be difficult to maintain once a lesion or polyp is detected and/or during a therapeutic, diagnostic, or biopsy procedure. Due to gravity, the endoscope tip may not stay centered within the colon and may instead fall against the wall of the colon. As a colonoscope is inserted or withdrawn, the tip may slide and drop inconsistently along the colon as it moves over the folds. This movement and/or the effect of gravity may cause the clinician to become disoriented, lose visualization, or lose positioning. If tip position is lost, time must be taken to again relocate the region of interest.
Additionally, the tortious nature of the gastrointestinal tract may make it difficult for a clinician to navigate the endoscope to the region of interest. The turns of the bowel, folded surface of the colon, and effects of gravity may cause the endoscope to bump and press on the body lumen as the endoscope is advanced or withdrawn. This may lead to stretching of the bowel, perforation, bleeding, trauma to the mucosa, inflammation, or other injury. As a result, the patient may experience pain, the patient's recovery time may increase, procedure time may increase, or the procedure may even need to be aborted prematurely.
A number of products have attempted to address the challenges associated with endoscopic procedures. For example, active balloon endoscopes and balloon attachments have been developed. The balloons are inflated once inserted into the colon to assist with withdrawal and visualization. However, these devices may be complex to manufacture and use due to the need for inflation and deflation mechanisms and the delicateness of the expanding portions. Additionally, active balloons that form a permanent part of an endoscope make scope-reprocessing (e.g., high level cleaning and disinfection) more challenging.
Other distal endoscope attachments that have rows of protrusions have been developed to aid in opening up colonic folds. However, the protrusions of those devices typically provide very similar stiffness and resistance to force in the direction of insertion and the direction of withdrawal. However, when inserting an endoscope, it is desirable to have reduced resistance on the distal tip. Since insertion involves two motions, linear advance and torqueing, the resistance to both of those motions should be low. Upon withdrawal, a device should engage with the colon to open the folds. This means that protrusions should be compliant and have low flexing and torqueing stiffness upon insertion, and should be configured to interact and engage with the colon and have relatively higher flexing stiffness upon withdrawal. If the protrusions are stiff upon insertion, this may cause increased insertion resistance, which then might cause the scope to loop and stretch the colon walls. This might produce mucosal trauma as the endoscope is inserted or withdrawn. Additionally, the force applied by the tips of the protrusions to discrete surface areas of the wall of the body lumen may increase mucosal trauma or cause perforation. On the other hand, if the protrusions are not stiff on withdrawal, they may not be capable to open the colonic folds and may not help with visualization of the regions adjacent the folds, as intended.
Accordingly, an improved endoscope attachment device is needed that is more compliant upon insertion and has a higher resistance to force upon withdrawal. Such a device may be capable of safely and effectively reducing the time taken for a clinician to perform an endoscopic procedure and for increasing the effectiveness of the procedure.
The device of the present disclosure aims to overcome the limitations of the prior art by facilitating one or more of the following: low resistance in an insertion direction; more effective opening of folds on withdrawal, steadying and/or centering the endoscope tip's position during a medical procedure; reducing the potential for mucosal trauma; and/or providing better physical and/or visual access around colonic folds.